BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARUS CAP SCREW ASSEMBLY

    MDR report key: 3842941 · Received May 12, 2014

    Report

    Report Number
    3025141-2014-00082
    Event Type
    Injury
    Date Received
    May 12, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K920666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00080-ROD P/N HR-L1115-S, MDR 3025141-2014-00081-SCREW 1 P/N HC03275-S, MDR 3025141-2014-00083-SCREW 2 P/N HCA-L5340-S. MDR 3025141-2014-00084-SCREW 3 P/N HCA-L5345-S, MDR 3025141-2014-00085-SCREW 4 P/N HCA-L5335-S.

    Description of Event or Problem · 1

    A POLARUS HUMERAL ROD WAS IMPLANTED FOR A SUBCAPITAL HUMERUS FRACTURE. FOLLOWING IMPLANTATION, THE HEAD OF THE BONE DISINTEGRATED DUE TO FRACTURE LINES NOT SEEN ON X-RAYS, CAUSING THE HUMERAL ROD TO DISLOCATE. THE 5.3MM SCREWS HAD BACKED OUT OF THE ROD. THE ROD AND THE SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284443 POLARUS CAP SCREW ASSEMBLY SCREW, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC HR-0050-S

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention